Full TitlePhase II Randomized Trial of Nivolumab with or without Ipilimumab in Patients with Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer (NRG-GY003) (CIRB)
The purpose of this study is to determine the safety and effectiveness of giving the drug nivolumab alone or in combination with ipilimumab in women with ovarian, primary peritoneal, or fallopian tube cancers that have continued to grow or came back despite other treatments.
Nivolumab is a form of immunotherapy. It boosts the body’s immune system by targeting a protein on white blood cells called PD-1. PD-1 normally maintains the balance of the immune system by shutting it down at the right time. Some cancers take advantage of this mechanism by expressing PD-L1, enabling them to escape attack by the body’s white blood cells. Nivolumab blocks PD-1, enhancing the body’s ability to detect and destroy cancer cells.
Ipilimumab is another form of immunotherapy. It is an antibody against CTLA-4, a molecule that controls a part of the immune system by shutting it down at the right time. Ipilimumab is already approved for treating melanoma, and prior studies have shown that combining it with nivolumab can be very effective for shrinking melanoma tumors. Nivolumab is approved for treating several types of cancer. The use of nivolumab and ipilimumab in this study is considered investigational.
Patients in this study will be randomly assigned to receive nivolumab alone or nivolumab plus ipilimumab. Both drugs are given intravenously (by vein).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have ovarian, primary peritoneal, or fallopian tube cancer that continued to grow or came back after no more than three regimens of chemotherapy (no more than two regimens for persistent or recurrent disease). At least one regimen must have included a platinum-containing drug.
- At least 4 weeks must pass between completion of prior therapies and entry into the study.
- Patients cannot have any history of autoimmune disease.
- Patients must be able to be walk and do routine activities for more than half of their normal waking hours.
- This study is for patients age 18 and older.
For more information and to inquire about eligibility for this study, please contact the Immunotherapeutics Clinic at 646-888-3359.